CN114588228B

CN114588228B - Composition for treating type 2 diabetes

Info

Publication number: CN114588228B
Application number: CN202110707806.4A
Authority: CN
Inventors: 胡天宝; 何宗源; 胡薇
Original assignee: Beijing Jingyihesheng Pharmaceutical Technology Co ltd
Current assignee: Beijing Jingyihesheng Pharmaceutical Technology Co ltd
Priority date: 2021-06-24
Filing date: 2021-06-24
Publication date: 2022-12-30
Anticipated expiration: 2041-06-24
Also published as: CN114588228A

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a composition for treating type 2 diabetes. The composition comprises the following components in parts by weight: 5-10 parts of lily, 1-10 parts of radix rehmanniae, 1-10 parts of rhizoma anemarrhenae, 1-10 parts of coptis chinensis, 1-5 parts of trichosanthes root, 1-5 parts of calcined oyster and 1-5 parts of trichosanthes bark. The preparation method comprises decocting Bulbus Lilii, radix rehmanniae, rhizoma anemarrhenae, coptidis rhizoma, trichosanthis radix, concha Ostreae preparata and pericarpium Trichosanthis in water to obtain decoction, filtering, and concentrating. The composition has simple medicinal flavor and strong operability of the preparation method, and can basically realize the elimination effect of insulin resistance.

Description

Composition for treating type 2 diabetes

Technical Field

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a composition for treating type 2 diabetes.

Background

Diabetes is a metabolic disorder syndrome characterized clinically by chronic hyperglycemia due to relative and/or absolute deficiency of insulin secretion. Among them, type 1 diabetes is mainly manifested as typical "more than three and one less" symptoms, i.e., polydipsia, polyphagia, diuresis and emaciation; while the type 2 diabetes patients are usually hidden and slow in onset, the symptoms of more than three and one less than three are light, even some patients have no obvious symptoms, and the patients are diagnosed when the blood sugar is higher due to physical examination. With the improvement of living standard and the change of life style, diabetes becomes the third most serious non-infectious disease after malignant tumor and cardiovascular and cerebrovascular diseases.

The modern medicine for treating type 2 diabetes mainly comprises biguanide hypoglycemic agent, alpha-glycosidase inhibitor acarbose and voglibose, insulin sensitizer rosiglitazone and pioglitazone, insulin secretagogue sulfonylurea and glinides and insulin. All the above treatments are maintenance treatments, and cannot improve the pathology fundamentally. The overall view and dialectical treatment of the traditional Chinese medicine provide a good idea for the overall metabolic regulation of diabetes.

Chinese ancient times do not have the name of diabetes, and according to the symptom, diabetes is probably the so-called diabetes in the present time. The causes of diabetes are discussed in detail in the interior meridians as early as, and the book of Ling Shu indicates that "Piandan" is the cause of obesity and beauty ", the book of Su Wen (plain questions) is the cloud of Fei Gui ren, the disease of sorghum is also the cause of" change of sorghum, zhang Sheng Da Ding ", which are summarized as the causes of high nutrition. The main pathogenesis of diabetes is intense stomach fire and deficiency of kidney yin. When the stomach fire is exuberant, the food is decayed, which leads to hyperphagia and hyperphagia; deficiency of kidney yin causes deficient fire to be endogenous, and inflammation of heart and lung causes polydipsia (upper warmer); the spleen and stomach are burned, the spleen does not disperse essence, and the food essence is discharged slightly, so that the urine is rich and sweet; kidney deficiency with failure to consolidate can cause diuresis (descending). For upper-warmer, it is advisable to moisten lung and clear stomach; for middle-jiao, it is advisable to clear stomach and nourish kidney; for lower energizer, it is indicated for nourishing kidney and lung. The general treatment principle is to treat the symptoms in case of emergency, treat the root cause in case of slow, and take the root cause and symptoms into consideration.

Chinese patent CN1241634C discloses a new medicine for treating diabetes, which comprises radix Saposhnikoviae, rhizoma cimicifugae, radix Puerariae, radix Trichosanthis, radix bupleuri, radix Glycyrrhizae, radix Ginseng, rhizoma Zingiberis, radix Aconiti lateralis Preparata, semen Coicis, radix scrophulariae, radix Ophiopogonis, radix asparagi, rhizoma Coptidis, cortex Phellodendri, rhizoma Atractylodis Macrocephalae, colla cornus cervi, bulbus Fritillariae Cirrhosae, radix Scutellariae, fructus Corni, radix rehmanniae, radix Paeoniae alba, colla Corii Asini, concha Haliotidis, mirabilitum crystallina, talcum, rhizoma anemarrhenae, concha Cudraniae, concha Ostreae, succinum, semen Benincasae Gypsum Fibrosum, etc. The formula has effects of improving pancreatic islet function, reducing blood lipid and lowering thrombi. However, the medicinal flavor is complex, and the function of improving the pancreatic island needs to be further improved.

The Chinese patent CN105147993A discloses a medicament for treating senile diabetes, which is prepared from the following Chinese medicinal materials in part by weight: 12 parts of rhizoma atractylodis, 10 parts of radix rehmanniae recen, 8 parts of coptis chinensis, 6 parts of radix bupleuri, 15 parts of radix trichosanthis, 8 parts of oyster, 8 parts of rhizoma anemarrhenae, 30 parts of Chinese yam, 8 parts of betel nut, 6 parts of very crisp tera, 8 parts of sugar palm, 4 parts of liquorice, 6 parts of Mayue tea, 5 parts of aizoon stonecrop herb, 4 parts of platycodon grandiflorum, 6 parts of donkey milk, 6 parts of pine needle, 5 parts of trona, 6 parts of staphylianthus, 18 parts of rhizoma polygonati, 8 parts of radix scrophulariae, 6 parts of radix ophiopogonis, 8 parts of black sesame, 6 parts of radix paeoniae alba and 6 parts of soybean steamed roll. The invention has the advantages of various medicinal herbs, unobvious treatment effect and unobvious improvement effect on insulin resistance of type 2 diabetes mellitus.

Disclosure of Invention

Aiming at the defects in the prior art, the invention provides the composition which has simple medicinal flavor and strong operability of the preparation method and can basically realize the function of eliminating insulin resistance.

The purpose of the invention is realized by the following technical scheme:

the composition for treating diabetes is characterized by comprising the following components in parts by weight: 5-10 parts of lily, 1-10 parts of radix rehmanniae, 1-10 parts of rhizoma anemarrhenae, 1-10 parts of coptis chinensis, 1-5 parts of trichosanthes root, 1-5 parts of calcined oyster shell and 1-5 parts of trichosanthes bark.

Preferably, the composition comprises the following components in parts by weight: 5-8 parts of lily, 1-5 parts of radix rehmanniae, 1-5 parts of rhizoma anemarrhenae, 1-5 parts of coptis chinensis, 3-5 parts of trichosanthes root, 3-5 parts of calcined oyster and 1-3 parts of trichosanthes bark.

Preferably, the mass ratio of the coptis chinensis to the radix trichosanthis to the rhizoma anemarrhenae is 0.5-2:0.5-1:1.

Preferably, the composition comprises the following components in parts by weight: 7 parts of lily, 5 parts of radix rehmanniae, 4 parts of rhizoma anemarrhenae, 4 parts of coptis chinensis, 3 parts of trichosanthes root, 3 parts of calcined oyster and 2 parts of trichosanthes bark.

The efficacy of each medicine in the formula of the invention is as follows:

lily: sweet and slightly cold. Enter heart and lung meridians. Has effects of moistening lung, relieving cough, calming heart and tranquilizing mind, and can be used for treating lung dryness or cough due to lung heat.

Radix rehmanniae: clear heat and cool blood, nourish yin, promote the production of body fluid. Can be used for treating pyrexia, dark-red tongue, polydipsia, yin deficiency, internal heat, bone steaming, fatigue heat, internal heat, diabetes, hematemesis, epistaxis, speckle and eruption.

Rhizoma anemarrhenae: is dried rhizome of Anemarrhena asphodeloides Bunge of Liliaceae. Clear heat and purge fire. Nourish yin to reduce fire, moisten dryness and smooth intestines. It is indicated for dysphoria with smothery sensation, diabetes, bone-steaming, fatigue-heat, cough due to lung-heat, dry stool and dysuria.

Coptis chinensis: clear heat and dry dampness, purge fire and remove toxicity. Can be used for treating damp-heat distention, fullness, emesis, acid regurgitation, dysentery, jaundice, hyperpyrexia, coma, excessive heart-fire, vexation, insomnia, hematemesis, hemorrhage, conjunctival congestion, toothache, diabetes, carbuncle, furuncle, etc.; it is used externally to treat eczema, eczema and purulent ear canal. Jiu Huang is good at clearing heat from upper energizer. Can be used for treating conjunctival congestion and aphtha.

Trichosanthes root: clearing heat and promoting fluid production, and can be used for treating fever, body fluid consumption, thirst, diabetes, etc.

Calcining oysters: astringe and induce astringency, relieve hyperacidity and alleviate pain, tranquilize mind, soften hardness and dissipate nodulation.

And (3) snakegourd peel: clear lung heat and resolve phlegm, promote qi circulation, relieve chest stuffiness and dissipate nodulation.

It is a further object of the present invention to provide a process for preparing the above composition, comprising the steps of: decocting Bulbus Lilii, radix rehmanniae, rhizoma anemarrhenae, coptidis rhizoma, trichosanthis radix, concha Ostreae preparata and pericarpium Trichosanthis in water to obtain decoction, filtering, concentrating, and concentrating to obtain the final product, or concentrating and drying to make into oral preparation, preferably granule.

Preferably, soaking for 20-40min before decocting; the drying is vacuum drying under reduced pressure.

Preferably, the volume ratio of the water to the total mass of the lily, the radix rehmanniae, the rhizoma anemarrhenae, the coptis chinensis, the radix trichosanthis, the calcined oyster and the snakegourd peel is 6-10:1mL/g.

Preferably, the decocting is to decoct lily, calcined oyster and snakegourd peel together, then decoct radix rehmanniae, rhizoma anemarrhenae, coptis chinensis and trichosanthes root together, and then mix the solution extracted by the decoction to obtain the decoction.

Preferably, the dried rehmannia root, the rhizoma anemarrhenae, the coptis root, the Mongolian snakegourd root and the snakegourd peel are crushed and sieved by a sieve with 10-24 meshes before decoction.

The invention also aims to provide the application of the composition in preparing a medicament for treating diabetes.

Compared with the prior art, the invention has the beneficial effects that:

(1) In the formula, the lily is sweet and slightly bitter in taste and slightly cold in nature, and has the effects of nourishing yin, moistening lung, clearing heart fire and soothing nerves, and the lily enters heart and lung channels. Radix rehmanniae is sweet and bitter in taste; slightly cold in nature; they enter heart, liver and kidney meridians. The medicine has the effects of clearing heat and cooling blood, nourishing yin, and promoting fluid production, and can be used for treating yin deficiency fever and the like. The two herbs have more obvious effects of nourishing yin, clearing heat and tonifying heart and lung, and are monarch drugs together. Rhizoma anemarrhenae is bitter and sweet in taste and cold in nature, and has the effects of clearing heat and purging fire, nourishing yin and moistening dryness; the trichosanthes root is sweet and slightly bitter in taste and slightly cold in nature, has the functions of clearing heat and promoting the production of body fluid, and is used as a ministerial drug for cooling and moistening internal consumption yin, clearing excess heat of lung and stomach, nourishing yin, promoting the production of body fluid and quenching thirst. The coptis chinensis is bitter in taste and cold in nature, the peel of the fructus trichosanthis is cold in nature and sweet in taste, and can clear away lung heat, and the two medicines are used together with the lily to clear away the fire in the upper middle warmer; calcined oyster is salty in taste and slightly cold in nature, has the efficacy of astringing and arresting discharge, can assist the dried rehmannia root to nourish kidney yin to relieve the symptom of diuresis, and can assist lily to nourish yin and moisten lung. The medicines in the formula are organically combined and supplement each other to play the effects of nourishing yin, clearing heat, reinforcing kidney and nourishing yin.

(2) The components supplement each other, and the snakegourd peel has the effects of clearing lung heat, has obvious synergy with the lily, clearing heat of upper middle jiao, assisting yin nourishing, moistening lung, clearing heart fire and soothing nerves, and has obvious treatment effect on type 2 diabetes.

(3) The traditional Chinese medicine is suitable for patients with type 2 diabetes and obesity, and has the effect of reducing uric acid for patients with dysphoria with smothery sensation in chest, hectic fever, night sweat, vigorous appetite, polydipsia, red tongue with little coating and thready and rapid pulse.

Drawings

FIG. 1 shows the glycated hemoglobin (HbA 1 c) values before and after inclusion in a patient;

FIG. 2 is the fasting and 2-hour post-prandial blood glucose values before and after inclusion in a patient;

FIG. 3 is the blood uric acid values before and after the inclusion of the patient's treatment.

Detailed Description

The invention is further illustrated by the following specific examples.

Example 1

The composition for treating diabetes comprises the following components in parts by weight: 5 parts of lily, 2 parts of radix rehmanniae, 2 parts of rhizoma anemarrhenae, 1 part of coptis chinensis, 1 part of trichosanthes root, 1 part of calcined oyster and 1 part of trichosanthes bark.

The preparation method of the composition comprises the following steps:

pulverizing Bulbus Lilii, radix rehmanniae, rhizoma anemarrhenae, coptidis rhizoma and pericarpium Trichosanthis, sieving with 10 mesh sieve, mixing with Trichosanthis radix and Concha Ostreae preparata, decocting with 6 times of water, filtering, and concentrating to 1/3 of the decoction.

Example 2

The composition for treating diabetes comprises the following components in parts by weight: 10 parts of lily, 10 parts of radix rehmanniae, 8 parts of rhizoma anemarrhenae, 10 parts of coptis chinensis, 6 parts of trichosanthes root, 5 parts of calcined oyster and 5 parts of trichosanthes bark.

The preparation method of the composition comprises the following steps:

pulverizing Bulbus Lilii, radix rehmanniae, rhizoma anemarrhenae, coptidis rhizoma and pericarpium Trichosanthis, sieving with 24 mesh sieve, mixing with Trichosanthis radix and Concha Ostreae preparata, decocting with 10 times of water, filtering, and concentrating to 1/3 of the decoction.

Example 3

The composition for treating diabetes comprises the following components in parts by weight: 7 parts of lily, 5 parts of radix rehmanniae, 4 parts of rhizoma anemarrhenae, 4 parts of coptis chinensis, 3 parts of trichosanthes root, 3 parts of calcined oyster and 2 parts of trichosanthes bark.

The preparation method of the composition comprises the following steps:

pulverizing Bulbus Lilii, radix rehmanniae, rhizoma anemarrhenae, coptidis rhizoma and pericarpium Trichosanthis, sieving with 24 mesh sieve, mixing with Trichosanthis radix and Concha Ostreae preparata, decocting with 8 times of water, filtering, and concentrating to 1/3 of the decoction.

Example 4

The preparation method of the composition comprises the following steps:

firstly, crushing lily and snakegourd peel, sieving the crushed lily and snakegourd peel by a sieve of 10 meshes, mixing the crushed lily and snakegourd peel with calcined oyster, adding 8 times of water, decocting and filtering to obtain a mixed decoction solution 1; pulverizing radix rehmanniae, rhizoma anemarrhenae and Coptidis rhizoma, sieving with 24 mesh sieve, mixing with Trichosanthis radix, decocting with 8 times of water, filtering to obtain decoction 2, mixing the decoction 1 and the decoction 2, and concentrating to 1/3 of the decoction.

Comparative example 1

The difference between this comparative example and example 3 is that lily is removed, the number of parts of snakegourd peel is adjusted to 9 parts, and the rest is the same as example 3.

Comparative example 2

The difference between this comparative example and example 3 is that the peel of snakegourd fruit was removed, the part of lily was adjusted to 9 parts, and the rest was the same as example 3.

Comparative example 3

The difference between this comparative example and example 3 is that the proportions of rhizoma anemarrhenae, radix Trichosanthis and rhizoma Coptidis are different, and the rest are the same as example 3. The specific method comprises the following steps:

the composition for treating diabetes comprises the following components in parts by weight: 7 parts of lily, 5 parts of radix rehmanniae, 2 parts of rhizoma anemarrhenae, 5 parts of coptis chinensis, 4 parts of trichosanthes root, 3 parts of calcined oyster and 2 parts of trichosanthes bark.

The preparation method of the composition comprises the following steps:

pulverizing Bulbus Lilii, radix rehmanniae, rhizoma anemarrhenae, coptidis rhizoma and pericarpium Trichosanthis, sieving with 24 mesh sieve, mixing with Trichosanthis radix and Concha Ostreae preparata, decocting with 6-10 times of water, filtering, and concentrating to 1/3 of the decoction.

Comparative example 4

The difference between this comparative example and example 3 is that radix rehmanniae was adjusted to be radix scrophulariae, rhizoma coptidis was adjusted to be poria cocos and cortex phellodendri, and lily was adjusted to be radix ophiopogonis, and the rest was kept the same as example 3. The specific method comprises the following steps:

the composition for treating diabetes comprises the following components in parts by weight: 7 parts of lily, 5 parts of figwort root, 4 parts of rhizoma anemarrhenae, 2 parts of phellodendron, 2 parts of tuckahoe, 3 parts of trichosanthes root, 3 parts of calcined oyster and 2 parts of trichosanthes bark.

The preparation method of the composition comprises the following steps:

pulverizing Bulbus Lilii, radix scrophulariae, rhizoma anemarrhenae, cortex Phellodendri, poria and pericarpium Trichosanthis, sieving with 24 mesh sieve, mixing with Trichosanthis radix and Concha Ostreae preparata, decocting with 8 times of water, filtering, and concentrating to 1/3 of the decoction.

Test example 1 animal pharmacodynamic test

1.1 purpose of experiment: the composition has blood sugar lowering effect on type 2 diabetes model rats.

1.2 Experimental animals and groups: SD male rats weighing 200 + -20 g, and 11 groups, blank group, model group, positive group, examples 1-4 group, comparative examples 1-4 group, and 10 rats each.

1.3 establishment of model rat

Except for free diet of blank group, feeding rats of other groups with high-sugar high-fat feed (10% sucrose, 2% cholesterol, 10% lard, 10% egg yolk powder and 68% basal feed), injecting 30mg/kg of STZ solution into abdominal cavity of rat after 4 weeks, collecting blood from tail vein after normal feeding for 72h, measuring blood sugar, wherein the blood sugar value is higher than 11mmmol/L, and modeling is successful.

1.4 test methods

And (5) performing intragastric administration. The concentrated solution (30 g/kg of crude drug) prepared in the corresponding group is administered to the groups of examples 1-4 and comparative examples 1-4, and the concentrated solution with the corresponding dosage is continuously concentrated to 4mL before the administration by gastric lavage; the model group and the blank group are given distilled water with the same volume, the positive control group is given metformin hydrochloride tablet suspension of 150mg/kg and the administration volume of 2mL/100g, and the administration is carried out once a day for 3 weeks by continuous intragastric administration. After the last administration for 12h, pentobarbital sodium is injected into the abdominal cavity to anaesthetize the rat, and the eyeball blood collection is carried out to measure the fasting blood glucose value and the insulin level before and after the administration; insulin sensitivity index = -In (blood glucose level x insulin level); and the blood uric acid level of the rat is measured.

(2) Analysis of results

SPSS13.0 statistical software is adopted for data processing, variance analysis and t test are adopted for comparison among groups, and P <0.05 is a difference with statistical significance. The results are shown in Table 1.

TABLE 1 levels of blood glucose, insulin and blood uric acid after administration to rats in each group

Note: different letters in the same column represent a statistical difference between the corresponding groups, P < 0.05.

Test example 2 clinical study

Clinical observation was carried out on 30 type 2 diabetic patients according to the guidelines on clinical study of new drugs containing Chinese herbs, wherein the differences between sex and age were statistically insignificant (P > 0.05) in 15 male patients and 15 female patients.

30 patients took the concentrate prepared in example 3, one dose per day, which was 240g in terms of crude drug amount. The administration is continued for 3 months.

According to statistics, the HbA1c of the patients before treatment (month 0) is 8.3 +/-1.9 (mean +/-standard deviation), the HbA1c of the patients after treatment (month 3) is remarkably reduced to 6.8 +/-1.0, and the difference has statistical significance (figure 1, ^**** P<0.0001). The patient has fasting blood glucose at 10.03 + -3.06 mmol/L before treatmentReducing the concentration to 6.99 +/-1.47 mmol/L; the blood glucose decreased from 14.58 + -4.53 mmol/L to 8.77 + -4.23 mmol/L2 hours after meal, the difference was statistically significant (FIG. 2, ^**** P<0.0001， ^#### P<0.001)。

in addition, the uric acid content of the patients before treatment (month 0) was 323.4. + -. 76.8. Mu.l/L (mean. + -. Standard deviation), and after treatment (month 3) was 294.2. + -. 56.4. Mu.l/L, with statistical differences (see FIG. 3, ^** P<0.01)。

the above detailed description is directed to one of the possible embodiments of the present invention, which is not intended to limit the scope of the invention, but rather the scope of the invention is intended to include all equivalent implementations or modifications without departing from the scope of the invention.

Claims

1. The composition for treating type 2 diabetes is characterized by comprising the following components in parts by weight: 5-10 parts of lily, 1-10 parts of radix rehmanniae, 1-10 parts of rhizoma anemarrhenae, 1-10 parts of coptis chinensis, 1-5 parts of trichosanthes root, 1-5 parts of calcined oyster and 1-5 parts of trichosanthes bark; the mass ratio of the coptis chinensis to the radix trichosanthis to the rhizoma anemarrhenae is 0.5-2:0.5-1:1.

2. The composition according to claim 1, wherein the composition consists of the following components in parts by weight: 5-8 parts of lily, 1-5 parts of radix rehmanniae, 1-5 parts of rhizoma anemarrhenae, 1-5 parts of coptis chinensis, 3-5 parts of trichosanthes root, 3-5 parts of calcined oyster and 1-3 parts of trichosanthes bark.

3. The composition according to claim 1, wherein the composition consists of the following components in parts by weight: 7 parts of lily, 5 parts of radix rehmanniae, 4 parts of rhizoma anemarrhenae, 4 parts of coptis chinensis, 3 parts of trichosanthes root, 3 parts of calcined oyster and 2 parts of trichosanthes bark.

4. A method of preparing a composition according to any one of claims 1 to 3, comprising the steps of: decocting Bulbus Lilii, radix rehmanniae, rhizoma anemarrhenae, coptidis rhizoma, trichosanthis radix, concha Ostreae preparata and pericarpium Trichosanthis in water to obtain decoction, filtering, concentrating, or concentrating and drying to obtain oral preparation.

5. The method for preparing according to claim 4, wherein the oral preparation is a granule.

6. The preparation method according to claim 4, wherein the soaking is performed for 20-40min before the decoction; the drying is vacuum drying under reduced pressure.

7. The method according to claim 4, wherein the ratio of the volume of the added water to the total mass of the lily, the rehmannia root, the rhizoma anemarrhenae, the coptis root, the trichosanthes root, the calcined oyster shell and the trichosanthes bark is 6-10:1mL/g.

8. The preparation method according to claim 4, wherein the decocting comprises decocting Bulbus Lilii, concha Ostreae preparata and pericarpium Trichosanthis, decocting radix rehmanniae, rhizoma anemarrhenae, coptidis rhizoma and Trichosanthis radix, and mixing the decoctions.

9. The preparation method according to claim 4, wherein the rehmannia root, the rhizoma anemarrhenae, the coptis root and the snakegourd peel are crushed and sieved by a 10-24-mesh sieve before decoction.

10. Use of a composition according to any one of claims 1 to 3 or a composition prepared by a process according to any one of claims 4 to 9 in the manufacture of a medicament for the treatment of diabetes.